TPLC - Total Product Life Cycle

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Device	folders and injectors, intraocular lens (iol)
Regulation Description	Intraocular lens guide.
Product Code	MSS
Regulation Number	886.4300
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Damaged by Another Device	597	597
Device Contamination with Chemical or Other Material	382	382
Adverse Event Without Identified Device or Use Problem	227	227
Crack	200	200
Scratched Material	123	123
Material Split, Cut or Torn	120	120
Break	82	82
Defective Device	76	76
Failure to Eject	75	75
Contamination /Decontamination Problem	52	52
Material Twisted/Bent	47	47
Defective Component	43	43
Difficult to Advance	32	32
Contamination	29	29
Physical Resistance/Sticking	28	28
Insufficient Information	23	23
No Apparent Adverse Event	20	20
Particulates	18	18
Failure to Advance	18	18
Appropriate Term/Code Not Available	17	17
Use of Device Problem	16	16
Material Fragmentation	15	15
Inaccurate Delivery	11	11
Material Separation	10	10
Mechanical Problem	8	8
Activation, Positioning or Separation Problem	8	8
Device Difficult to Setup or Prepare	7	7
Material Deformation	6	6
Ejection Problem	6	6
Priming Problem	6	6
Unintended Ejection	6	6
Difficult to Remove	5	5
Burst Container or Vessel	5	5
Mechanical Jam	5	5
Material Rupture	4	4
Difficult to Insert	4	4
Improper or Incorrect Procedure or Method	4	4
Off-Label Use	3	3
Product Quality Problem	3	3
Device Handling Problem	3	3
Detachment of Device or Device Component	2	2
Failure to Deliver	2	2
Failure to Fold	2	2
Device Markings/Labelling Problem	2	2
Entrapment of Device	2	2
Fitting Problem	2	2
Material Too Rigid or Stiff	1	1
No Pressure	1	1
Stretched	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	907	907
Insufficient Information	749	749
No Known Impact Or Consequence To Patient	124	124
No Consequences Or Impact To Patient	52	52
Capsular Bag Tear	49	49
No Code Available	48	48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
Foreign Body In Patient	27	27
Eye Injury	23	23
Visual Impairment	22	22
Corneal Edema	14	14
Vitrectomy	13	13
Toxic Anterior Segment Syndrome (TASS)	12	12
Blurred Vision	10	10
Endophthalmitis	9	9
Visual Disturbances	9	9
Inflammation	8	8
Vitreous Loss	7	7
Eye Pain	7	7
Foreign Body Sensation in Eye	6	6
Loss of Vision	5	5
Uveitis	4	4
Iritis	4	4
Failure of Implant	4	4
Vitreous Floaters	4	4
Keratitis	4	4
Swelling/ Edema	4	4
Hypopyon	3	3
No Information	3	3
Corneal Abrasion	3	3
Unspecified Eye / Vision Problem	3	3
Fibrosis	2	2
Hemorrhage/Bleeding	2	2
Capsular Contracture	2	2
No Patient Involvement	2	2
Edema	2	2
Red Eye(s)	2	2
Wound Dehiscence	2	2
Intraocular Pressure Increased	2	2
Halo	2	2
Discomfort	1	1
Conjunctivitis	1	1
Unspecified Tissue Injury	1	1
Injury	1	1
Zonular Dehiscence	1	1
Hyphema	1	1
Corneal Decompensation	1	1
Corneal Touch	1	1
Macular Edema	1	1
Bacterial Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Rayner Intraocular Lenses Limited	II	Apr-21-2020